LONG-TERM HEALTH OUTCOMES USING THE INVESTIGATIONAL LECANEMAB SIMULATION MODEL IN PATIENTS WITH EARLY ALZHEIMER’S DISEASE PUBLISHED IN A PEER-REVIEWED JOURNAL, NEUROLOGY AND THERAPY

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TOKYO, April 26, 2022 /PRNewswire/ — Eisai Co., Ltd. (seat : TokyoCEO: Haruo Naito“Eisai”) today announced that a paper on the long-term health outcomes of its experimental anti-amyloid-beta (Aβ) protofibril antibody lecanemab in people with early-onset Alzheimer’s disease (AD) using simulation modeling has been published in a peer-reviewed journal Neurology and Therapy. In this simulation, treatment with lecanemab is believed to potentially slow the rate of disease progression, keeping treated patients longer in the early stages of mild cognitive impairment (MCI) due to AD and mild AD ( collectively, early MA).



The article describes the comparison of long-term clinical outcomes for people with early AD who have amyloid pathology with standard of care (SoC) alone (including stable use of acetylcholinesterase inhibitor or memantine ) and with lecanemab with SoC (lecanemab + SoC), using the disease simulation model (AD ACE model1.2) based on the results of a Phase IIb clinical trial (Study 201) evaluating the efficacy and safety of lecanemab. SoC data was estimated from the results of the ADNI (Alzheimer’s Disease Neuroimaging Initiative) study. The estimated lifetime risk of disease progression to mild, moderate, and severe AD dementia from baseline has been shown to potentially be reduced by 7%, 13%, and 10% with lecanemab + SoC, respectively. , compared to the SoC. In the model, the mean time to progression to mild, moderate, and severe AD dementia was longer for patients in the lecanemab-treated group than for patients in the SoC group by 2.51 years (SoC vs lecanemab+Soc: 3.10 vs 5.61 years), 3.13 (6.14 vs 9.27 years) and 2.34 (9.07 vs 11.41 years) respectively. Subgroup analysis by age and disease severity at baseline also revealed a potentially greater impact on disease progression with earlier initiation of lecanemab treatment. Mean incremental transition times to mild and moderate AD dementia were 2.53 and 3.34 years, respectively, when treating MCI due to AD in a subgroup analysis versus SoC.


“With a growing and aging global population, the number of people diagnosed with Alzheimer’s disease will only increase, making it an even more important and urgent public health priority. Alzheimer’s disease is a growing problem in terms of medical and nursing care costs, but also informal care costs by family, resulting in increased anxiety. Results from the simulation model suggest that early treatment with lecanemab may delay progression to the most severe stages of AD, potentially giving people living with early AD and their loved ones more time together and possibly reducing healthcare costs,” said Ivan CheungChairman, Eisai Inc., Senior Vice President, President Neurology Business Group and Global Alzheimer’s Disease Officer, Eisai Co., Ltd. lecanemab value. Ongoing Phase 3 studies will soon be able to inform model inputs and refine results. As part of Eisai’s commitment to our human health mission and transparency, we will continue to publish data and information about lecanemab.


Lecanemab obtained Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. Eisai expects to complete lecanemab’s ongoing submission of a biologics license application for the treatment of early-onset AD to the FDA under the accelerated approval pathway in the first quarter of fiscal year 2022 d ‘Eisai, who started April 1, 2022. Additionally, readout of the confirmatory Clarity AD Phase 3 clinical trial will take place in the fall of 2022. Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data from the lecanemab as part of the pre-assessment consultation system in Japan in March 2022. Eisai leads lecanemab development and regulatory submissions globally, with Eisai and Biogen co-marketing and co-promoting the product and Eisai having final decision-making authority.


This release discusses experimental uses of an agent under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or obtain approval from health authorities.


1 Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Archimedes’ condition event simulator of Alzheimer’s disease: development and validation. Alzheimer’s dementia (NEW YORK). 2018;4:76-88. Published February 16, 2018. doi:10.1016/j.trci.2018.01.001

2 Tafazzoli and Kansal. Disease simulation in drug development, external validation confirms benefits in decision-making. The Evidence Forum. 2018.
https://www.evidera.com/wp-content/uploads/2018/10/07-Disease-Simulation-in-Drug-Development_Fall2018.pdf


Media inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120


[Notes to editors]


1. About Lecanemab (BAN2401)
Lecanemab is an investigational humanized monoclonal antibody for Alzheimer’s disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab binds selectively to neutralize and eliminate soluble and toxic amyloid beta (Aβ) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may affect disease pathology and slow disease progression. Currently, lecanemab is under development as the only anti-Aβ antibody that can be used for the treatment of early AD without the need for titration. Regarding the results of the pre-specified analysis at 18 months of treatment, study 201 demonstrated a reduction in the accumulation of Aβ in the brain (P


Lecanemab is currently being studied in a confirmatory phase 3 clinical study in symptomatic early AD (Clarity-AD), following the results of the phase 2 clinical study (study 201). Since July 2020 the phase 3 clinical study (AHEAD 3-45) for people with preclinical AD, which means they are clinically normal and have intermediate or high levels of amyloid in their brain, is ongoing. AHEAD 3-45 is being conducted through a public-private partnership between the Alzheimer’s Clinical Trial Consortium which provides the infrastructure for academic clinical trials in AD and related dementias in the United States, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022the Tau NexGen Clinical Study in Dominant Inherited Alzheimer’s Disease (DIAD), which is being conducted by the Dominant Inherited Alzheimer’s Network Trials Unit (DIAN-TU), led by University of Washington School of Medicine Saint Louis, is in progress. Additionally, Eisai has initiated a Phase 1 study of subcutaneous administration of lecanemab. Eisai has been granted worldwide rights to study, develop, manufacture and commercialize lecanemab for the treatment of AD pursuant to an agreement entered into with BioArctic in December 2007.


* ADCOMS (AD Composite Score), developed by Eisai, combines items from the ADAS-Cog (AD Assessment Scale-cognitive subscale), Clinical Dementia Rating (CDR) and MMSE (Mini-Mental State Examination) scales to enable sensitive detection of changes in clinical functions of early symptoms of AD and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with a higher score indicating greater impairment.
**An estimated 80% or greater probability of demonstrating a slowing super superiority of 25% or greater in clinical decline at 12 months of treatment, as measured by ADCOMS from baseline versus placebo.


2. About the Eisai and Biogen collaboration for Alzheimer’s disease
Eisai and Biogen are collaborating on the joint development and commercialization of treatments for AD. Eisai is leading lecanemab development and regulatory submissions globally, with the two companies co-marketing and co-promoting the product.


3. About the Eisai and BioArctic collaboration for Alzheimer’s disease
Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement for the lecanemab antibody was signed in December 2007and the development and commercialization agreement for lecanemab rescue antibody for AD, which was signed in May 2015. Eisai is responsible for the clinical development, marketing authorization application and commercialization of AD products. BioArctic has no development costs for lecanemab in AD.




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SOURCEEisai Inc.

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